Archive | Regulatory

FDA Approves Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma Following CR

The FDA has approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection (CR).

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Posted in Melanoma News, Regulatory, Publications

FDA approves adjuvant Keytruda for certain adults, children with stage IIB, IIC melanoma

The FDA approved pembrolizumab as adjuvant therapy for adults and children aged 12 years or older with stage IIB or IIC melanoma after complete resection.

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Posted in Melanoma News, Regulatory, Publications

FDA Orphan Drug Designation Granted to ST101 for Advanced Cutaneous Melanomas

The FDA granted a fast track designation to ST101 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy.

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Posted in Melanoma News, Regulatory, Publications

NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma

The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund.

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Posted in Melanoma News, Regulatory, Publications